(MENAFN - ProactiveInvestors - Australia) Osprey Medical (ASX: OSP) has sparked some investor interest today with an almost 12% increase in its share price to an intra-day high of A0.38.
The company has regained some ground in recent weeks since trading at a low of 0.31 in late September.
Osprey is making substantial progress in getting its lead product, the CINCOR„ System, for the prevention of kidney damage to market.
Commercialisation is targeted for 2012. Indicating the potential revenues that can be achieved, the U.S. and western Europe addressable market represents between US600 and 800 million per annum.
Osprey already has CE Mark approval for the CINCOR„ System.
The CINCOR„ System reduces and removes a significant quantity of dye used to x-ray heart tissue during angioplasty, but can cause serious and irreversible damage to the kidneys.
Currently there is no good way of preventing dye from reaching the kidneys.
Osprey revealed earlier this week enhancements to the system that reduces the amount of x-ray dye that is used during common heart procedures.
Reducing the amount of dye, in addition to capturing and removing the dye that is used, is expected to protect the kidney from dye exposure and reduce the incidence of contrast induced nephropathy (CIN).
The new dye reduction system has been successfully used on 44 patients, including 14 at Melbourne's Baker IDI Heart and Diabetes Institute.
Following successful clinical trials across six sites in Australia, New Zealand and Europe, Osprey obtained CE Mark and plans to begin a controlled market launch of the CINCOR„ System in Europe in 2012.
The company has also obtained approval from the U.S. Food and Drug Administration (FDA) to conduct a registration-directed pivotal trial, which is planned for 2012.
Osprey is targeting FDA approval to enable a U.S. market launch of the CINCOR„ System in 2014.